Medical implant and manufacturing method thereof

ABSTRACT

A medical implantable occlusion device ( 100 ) is disclosed comprising a braiding of at least one thread, an expanded diameter portion ( 102 ), and a tubular member ( 103 ) having a distal endpoint closest to the expanded diameter portion having a distal rim ( 107 ). The braiding comprises a stem ( 108 ) having a first end connected to the expanded diameter portion and a second end connected to the distal region, where the stem in a relaxed state is partly sunk into the tubular member beneath the distal rim ( 107 ), wherein the proximal region comprises a connecting member ( 113 ), wherein ends of the at least one thread are fixed to the connecting member, the expanded diameter portion comprises returning loops of the at least one thread whereby opposite ends of the at least one thread forming the expanded diameter portion are fixed to the connecting member.

RELATED APPLICATIONS

This application claims priority to U.S. patent application Ser. No.13/698,978 filed Jun. 4, 2013 entitled Medical Implant And ManufacturingMethod Thereof, which is the U.S. National Phase of and claims priorityto International Patent Application No. PCT/EP2011/058381, InternationalFiling Date May 23, 2011, entitled Medical Implant And ManufacturingMethod Thereof, which claims benefit of European Application No.10163679.3, filed May 23, 2010 entitled Medical Implant AndManufacturing Method Thereof, and U.S. Provisional Application Ser. No.61/347,463, filed May 24, 2010 entitled Medical Implant AndManufacturing Method Thereof, all of which are incorporated herein byreference in their entireties.

FIELD OF THE INVENTION

This invention pertains in general to the field of medical implants, aswell as methods for manufacturing such implants. More particularly theinvention relates to an intraluminally deliverable occlusion device forselective occlusion of a target site in a body lumen, such as the body'scirculatory system.

BACKGROUND OF THE INVENTION

Various intravascular deliverable devices are used for treating specificconditions via access through body lumina, such as patients circulatorysystem. The target site may for instance be an atrial or ventricularseptum having a defective opening to be occluded, such as devices fortreating septal defects and the like. In certain circumstances, it maybe necessary to occlude a patient's lumen, vessel, chamber, channel,hole, or cavity such as to stop blood flow there through. One suchcondition known in the art is a patent ductus arteriosus (PDA), which isessentially a condition wherein two blood vessels, most commonly theaorta and pulmonary artery adjacent the heart, have a blood flow shuntbetween their lumens. Blood can flow directly between these two bloodvessels through the passageway, compromising the normal flow of bloodthrough the patient's vessels. Other physiologic conditions in the bodyoccur where it is also desirous to occlude a vessel, a shunt betweenvessels, or an ostium at a branch vessel, in order to prevent blood flowthrough the vessel.

An occlusion device for treatment of such heart disease is disclosed inUnited States patent application publication number 2009/0187214. Atubular member of a braided fabric is disclosed having disc-shapedportions connected to either side of the tubular member via transitionsegments having reduced cross-sectional dimension. The device isdelivered by a catheter connected to either of the discs. The discsengage with the walls of the septum. The diameter and length of the PDAis determined by angiography in order to select the size of the device,where the latter dimension requirement is a particular issue due to thedouble disc design, which furthermore is increasing the complexity ofthe device and the delivery thereof.

EP2014240 discloses a medical device having a cylindrical body portion,a disc portion, and a small transition diameter there between. Thetransition diameter is recessed within an indention. A problem with thedevice is lack of flexibility and compactness of the device.

A problem with prior art is to achieve sufficient flexibility whilemaintaining a compact device. This applies in particular during deliverythrough tortuous channels. Flexibility is also desired during deliverwhen releasing the implantable device out of a catheter to the targetsite. Moreover, a degree of flexibility to accommodate anatomicalmovements without fatigue or risk of loosening from the implantationsite during an ingrowth period is also a desired characteristic of suchdevices. Further, a compact device is desirable for quick and easydelivery, for example via a catheter, and for occupying less space inthe body, thereby reducing chance of interference with bodily functions.A more flexible implant is desired in terms of adjustments of the deviceused and applied methods, due to the fact that different patients areanatomically slightly different to one another and that the deficiencyto be treated is most often individual and unique for each patienttreated.

A problem with prior art is to achieve a secure attachment of the devicein the body while maintaining ease of delivery. Secure attachment isnecessary for patient safety and achieving the intended treatment of theseptal defect.

Thus, there is a need for an implant which adjusts for differences inthe cardiovascular system between patients still allowing a securedeployment of a medical implant.

Also, a problem with prior art is that delivery of the device via theaorta having a high pressurized blood environment may give rise toseveral undesired conditions. Debris, e.g. from arterioscleroticdeposits scraped loose by the device under delivery, for instance atostia of branch vessels, may cause embolic complications. Embolicmaterial could thus be transported to vital organs, e.g. to the brainvia the subclavian vessels, and cause blood clots, leading to stroke.

The above problems may have dire consequences for the patient and thehealth care system. Patient risk is increased.

Hence, an improved implant would be advantageous and in particularallowing for increased flexibility, cost-effectiveness, and/or patientsafety would be advantageous. Also, and a method for manufacturing suchmedical implant would be advantageous.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present invention preferably seeks tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a device and a method according to the appendedpatent claims.

Embodiments of the present invention may be well suited for theselective occlusion of a vessel, lumen, channel, hole, cavity, or thelike. One particular example, without limitation, of such a condition isa Patent Ductus Arteriosus (hereinafter PDA). Another example is avessel, lumen, channel, hole or shunt, through which blood flows fromone vessel to another vessel such as an Atrial Septal Defect (hereinafter ASD) or a Ventricular Septal Defect (herein after VSD). Otherexamples could be an Arterial Venous Fistula (AVF), Arterial VenousMalformation (AVM), a Patent Foramen Ovale (PFO), or a Para-ValvularLeak (PVL).

According to a first aspect of the invention a medical implantableocclusion device is provided comprising a braiding of at least onethread, where the braiding has an unloaded relaxed state and a stretchedstate. The braiding comprises an expanded diameter portion, and atubular member extending along a longitudinal axis. The tubular memberhas a distal region towards the expanded diameter portion and anopposite proximal region, where a distal endpoint of the distal regionclosest to the expanded diameter portion has a distal rim in a planesubstantially orthogonal to the longitudinal axis. The braidingcomprises a stem having a first end connected to the expanded diameterportion and a second end connected to the distal region, where the stemin the relaxed state is partly sunk into the tubular member beneath thedistal rim whereby the second end of the stem is displaced from thedistal rim by a first offset along the longitudinal axis. The proximalregion comprises a connecting member for a delivery device, wherein endsof the at least one thread are fixed to the connecting member, andwherein the expanded diameter portion comprises returning loops of theat least one thread whereby opposite ends of the at least one threadforming the expanded diameter portion are fixed to the connectingmember.

According to a second aspect of the invention a method of manufacturinga medical implantable occlusion device of a braiding of at least onethread is provided. The method comprises forming the braiding in a firstheat setting step to a first intermediate shape comprising a tubularmember and an expanded diameter portion, attaching a secondary tool tothe braiding having the first shape, and forming the braiding in asecond heat setting step to a second shape by the secondary tool, wherethe braiding partly maintains the first shape.

Further embodiments of the invention are defined in the dependentclaims, wherein features for the second and subsequent aspects of theinvention are as for the first aspect mutatis mutandis.

Some embodiments of the invention provide for flexible positioning of amedical implant to varying anatomical sites in a body of a human oranimal.

Some embodiments of the invention also provide for secure attachment ofa medical implant in a patient's vascular system.

Some embodiments of the invention provide for a compact medical implantwith maintained flexibility.

Some embodiments of the invention provide for a medical implant that canbe safely delivered to a treatment site in a patient.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 is an illustration of a medical implantable occlusion deviceaccording to an embodiment of the invention;

FIG. 2 is an illustration of a medical implantable occlusion deviceaccording to an embodiment of the invention;

FIG. 3 is a side view the medical implantable occlusion device in FIG.2;

FIGS. 4a-d are illustrations of a medical implantable occlusion deviceaccording to an embodiment of the invention during a manufacturing step;

FIG. 5 is a flow chart illustrating a method of manufacturing of amedical implantable occlusion device according to an embodiment of theinvention; and

FIG. 6 is a flow chart illustrating a method of occluding a shunt in abody lumen with a medical implantable occlusion device according to anembodiment of the invention.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

The following description focuses on an embodiment of the presentinvention applicable to a PDA plug. However, it will be appreciated thatthe invention is not limited to this application but may be applied tomany other medical implantable devices, including for example filters,stents, Left Atrial Appendage (LAA) occluders, aneurysm treatmentdevices, grafts, etc.

FIG. 1 shows a medical implantable occlusion device 100 according to anembodiment of the invention. The device 100 comprises a mesh or braiding101 of at least one thread. The braiding 101 may be formed from onethread or several. The device 100, or more particularly the braiding101, has an unloaded relaxed state and a stretched state. Thus, in therelaxed state, wherein the device 100 has a shape as depicted in FIG. 1,no external force acts on the device 100. The device 100 may bestretched and thereby exhibit a smaller cross-section, in order to fitinside a delivery device such as a catheter. The device 100 may beself-expandable between the stretched state and the relaxed state, i.e.when the device 100 is removed from the confinement of the catheter thecross-section of the device 100 returns to its originally defined valuein the unloaded relaxed state. The device may be self-expandable due toan inherent elasticity of the threads in the braiding. The device mayalso have a shape memory, e.g. triggerable to go to the relaxed state ata switching temperature, such as body temperature. Alternatively, or inaddition, in other embodiments of the implantable device, expansiondevices (not shown), such as inflatable balloons, may be used to bringthe device from the collapsed state to the expanded, relaxed state.

The shape of the device 100 in the relaxed state may be defined in aheat treatment procedure of the device 100 or more particularly of thebraiding 101. The dimensions of the device 100 in the relaxed state aredefined in the heat treatment procedure if the braiding. A particularembodiment of the manufacturing method is described below.

The entire device 100 may be comprised of a single, continuous braiding101. The braiding 101 may be made of a material suitable for implantingin a human or animal body, and suitable for being formed in a heattreatment procedure to a desired shape in the unloaded relaxed state andalso in the stretched state. For example NiTinol may be used as amaterial for the device 100. However, suitable materials for embodimentsof the braiding are various and include shape memory materials, metal,superelastic alloys (such as NiTinol), or polymers, such as degradablepolymers.

The braiding 101 comprises an expanded diameter portion 102, and atubular member 103 extending along a longitudinal axis 104. The tubularmember 103 has a distal region 105 towards the expanded diameter portion102 and an opposite proximal region 106. The distal region 105 comprisesa distal rim 107 corresponding to the distal endpoint of the distalregion 105 closest to the expanded diameter portion 102. The distal rim107 corresponds to the edge of the tubular member 103 that faces theexpanded diameter portion 102, and is aligned in a plane substantiallyorthogonal to the longitudinal axis 104.

The braiding 101 comprises a stem 108 having a first end 109 connectedto the expanded diameter portion 102 and a second end 110 connected tothe distal region 105 of the tubular member 103. In the unloaded relaxedstate of the device 101 as shown in FIG. 1 the stem 108 is partly sunkinto the tubular member 103 beneath the distal rim 107. Thus, the secondend 110 of the stem 108 is displaced from the distal rim 107 by a firstoffset 111 along the longitudinal axis 104.

The displacement of the stem 108 into the tubular member 103 provides amore compact device 100. As the length (E) of the stem 108 is maintainedwhile the device 100 is more compact, i.e. due to decreased length (D),the function of the stem 108 for providing flexibility between thetubular member 103 and the expanded diameter portion 102 is maintained.

By stretching the device 100, e.g. by moving the expanded diameterportion 102 and the tubular member 103 in opposite directions along thelongitudinal axis 104, the device 100 is put in the stretched state andthe first offset 111 may decrease. As the stem 108 is partially sunkinto the tubular member 103 the amount of displacement possible of thedevice 100 from the unloaded relaxed state, e.g. by aforementionedstretching, could be increase as the stem 108 may be stretched out ofthe tubular member 103, for example by an amount corresponding to theoffset 111 of the device in the relaxed state. Various offsets 111 maybe defined for the device 100 in the relaxed state.

Alternatively, or in addition, the length of the stem 108 maysubstantially remain constant without being stretched. This allows for aparticular stable long-term construction even in anatomical situationswhere a continuous movement at the implantation site is present. Thestem may be made of a portion of parallel threads or a more denselybraided section of the braiding 101 at the stem 108, providing forparticular strength in the longitudinal direction.

The distal region 105 has a curved braiding having an apex at the secondend 110 of the stem and a distal surface 112. This may provide aninherent flexibility in use, drawing the tubular part 103 and theexpanded diameter part 102 longitudinally towards each other. The shapeand spatial extent of the distal surface 112 provides a spring likeportion. This spring-like portion is shown left and right to thediameter G in FIG. 1. This provides for advantageously controllableself-contraction properties of the device 100. As substantially theentire distal surface 112 enclosed by the distal rim 107 is recessed, asseen in FIG. 1, the range of motion and flexibility or spring-likeaction is improved, as discussed further below. I.e. the diameter of therecessed distal surface 112 may be substantially equal to the diameterof the distal rim 107. Also the distal surface 112 may be substantiallyconcave towards the expanded diameter portion 102, as seen in FIG. 1,and/or having a portion close to the second end 110 extending radiallysubstantially parallel to the expanded diameter portion 102. Thisfurther allows for increased flexibility of the stem 108 and expandedportion 102 as the area of the flexible recessed surface 112 isincreased, as the amount of material being flexible is increased,without increasing the dimensions of the device 100 externally.

As the device 100 may strive towards the relaxed state by beingself-expandable, or rather self-contracting, between the stretched stateand the relaxed state, an inherent force may act on the stem 108 tomaintain the offset 111 as defined in the relaxed state. By removing theexternal forces on the device 100 and thereby release it from thestretched state, the braiding 101 may return to its original shape inthe relaxed state due to the aforementioned inherent force. The originalshape of the device 100 may be defined in a heat treatment procedure ina manufacturing step. The inherent force pulls the expanded diameterportion 102 towards the tubular member 103 as soon the stem 108 isdisplaced from the shape of the device 100 in the relaxed state. As thestem 108 is partially sunk into the tubular member 103 a largeflexibility is obtained as the device 100 may be stretched by expansionof the stem 108 from the tubular member 103 with reduction of the offset111 from its defined value in the relaxed state while the inherent forceact to contract the expanded diameter portion 102 towards the tubularmember 103. This is advantageous as a single device 100 can be appliedto occlude various PDA with different lengths while maintaining secureattachment of the device 100 at the PDA as the diameter portion 102 willbe contracted towards the tubular member 103 for each lengthconfiguration possible for the device 100, i.e. for each displacement ofthe stem 108 relative to the distal rim 107.

The tubular member 103 may comprise biocompatible fibres or patches offor example of PET that support sealing of the blood flow through thedevice 100, and thereby the shunt to be occluded.

The tubular member 103 may be tapered towards the expanded diameterportion 102. The diameter (B) of the endpoint of the proximal region 106is thereby larger than the diameter (A) of the endpoint of the distalregion 105. When positioned in the PDA the tapered shape towards theexpanded diameter portion 102 create an increased force acting on thewalls of the PDA to be occluded as the expanded diameter portion 102 ispulled towards the tubular member 102 by the aforementioned inherentforce if the device 100 is self-contracting. The proximal region 106will exert a compressive force towards the expanded diameter portion 102by the tapered configuration in comparison to a pure frictional force incase the device is not tapered, or tapered in the other direction. Thetapered shape, similar to a champagne cork, has a function similar to anoversized cork at one end, leading to improved retention in body lumina.This is in particular advantageous with shunts that anatomically have anincreasing lumen diameter in the same direction as the tapering andwhere the expanded diameter portion provides further increases lockingof the device in the shunt. In particular the expanded diameter portionis substantially flat and has a diameter larger than an ostium of theshunt into which it is placed. Thus the rim of the periphery of theexpanded diameter portion may advantageously engage the tissue aroundthe ostium. The closure effect is further improved when a higherpressure is applied from the distal side towards the distal end of thedevice, such as when the device 100 is arranged in a PDA. Here, thetubular portion is arranged in the shunt channel of the PDA and theexpanded diameter portion is arranged in the aortic arch around theostium of the PDA. Thus a secure occlusion is achieved even before thedevice is securely covered with endothelia and tissue integrated withthe surrounding tissue.

The distance (F) between the distal rim 107 and the expanded diameterportion 102 may be substantially smaller than the length of the stem108. By increasing the offset 111 in relation to the distance (F) a morecompact device 100 may be obtained while maintaining the flexibilitydiscussed above. The distance (F) may be increased so that the expandeddiameter portion 102 and the stem 108 may pivot more from side to sidewithout the expanded diameter portion 102 interfering with the distalrim 107.

The stem 108 may be pivotable with respect to the tubular member 103around the second end 110 of the stem 108. In this way the angle of theexpanded diameter portion 102 in relation to the tubular member 103 maybe changed depending on the anatomy of the site in the vascular systemto be occluded. The length (F) of the stem 108, and the amount of offset111 and distance (F) may affect the amount the stem 108 may be pivotedand thereby the amount of angular displacement of the expanded diameterportion 102.

The stem 108 may be concentric with respect to the tubular member 103. Asymmetric shape of the device 100 may increase the flexibility of theexpanded diameter portion 102 in relation to the tubular member 103. Anasymmetric configuration may be suitable in particular anatomies to beoccluded.

In FIG. 1 the second end 110 of the stem 108 is connected to the distalsurface 112 of the distal region 105. The distal surface 112 is sunkinto the tubular member 103 beneath the distal rim 107. As the secondend 110 of the stem 108 is connected to the distal surface 112 which issunk into the tubular member 103 beneath the distal rim 107 theflexibility of the stem 108 in relation to the tubular member 103 may beincreased. The entire distal surface 112 may be flexible to allowmovement of the stem 108 in relation to the tubular member 103. The stem108 may be flexible by itself as the braiding 101 forming the stem 108may provide for flexibility. Alternatively, or in addition, the stem 108may be of a flexible material. Tilting of the distal surface 110 inrelation to the longitudinal axis 104 may provide for increased angulardisplacement of the expanded diameter portion 102 in relation to thetubular member 103.

The distal surface 112 may be confined to a region of the braiding 101between the stem 108 and the distal rim 107. The diameter of the distalsurface 112 may be substantially equal to the diameter of the distal rim107, i.e. substantially equal to the diameter (A) in FIG. 1. Hence, thesurface of the braiding 101 inside the distal ring 107 is sunk into thetubular member 103. As a larger portion of the surface of the braidingbetween the second end 110 of the stem 108 and the distal rim 107 issunk into the tubular member 103 an increased range of motion may bepossible for the stem 108, and thereby an increased flexibility of theexpanded diameter portion 102. This is in contrast to cases where only aminor part of the distal surface is recessed, which could not providethe same range of motion of the distal surface 112 and thereby not thesame range of motion of the expanded diameter portion 102. Hence, insuch cases, the device will not be able to conform to such wide range ofanatomies as the device 100 of the current invention.

The expanded diameter portion 102 may be a disc shaped portion. The discmay be bent with its outer periphery closer towards the tubular portionthan the center portion thereof. Alternatively, it may have any shapesuitable for the particular anatomy of the site to be occluded.

The outer diameter (C) of the expanded diameter portion 102 may besubstantially larger than a diameter of the tubular member 103, asdepicted in FIG. 1. An increased diameter (C) may reduce the pressureexerted by the expanded diameter portion 102 on the vessel wall at theocclusion site, and decrease the risk of the device 100 being dislodgedfrom the occlusion site. The diameter may be equivalent to the largestcross-section throughout the disclosure.

The diameter (G) of the stem 108 may be substantially smaller than anydiameter of the tubular member (A, B). A smaller diameter may increasethe flexibility of the expanded diameter portion 102.

The proximal portion 102 may comprise a connecting member 113 for adelivery device (not shown). The delivery device may grasp theconnection member 113 which may be spherical in shape, thus providing apivoting motion of the device 100 in relation to the delivery device incombination with secure attachment. The ends of the at least one threadforming the braiding 101 may be fixed to the connecting member 113. Theconnecting member 113 may thus be a weld or any other attachment meansfor the threads of the braiding 101. The connecting member may comprisea threaded screw attachment (not shown) of female or male type forthreaded attachment to a delivery device having corresponding threads.The expanded diameter portion 102 may comprise returning loops of the atleast one thread, meaning that opposite ends of the at least one threadforming the expanded diameter portion 102 are fixed to the connectingmember 113. By having returning loops only one collection point for theends of the at least one thread is needed. The connection member 113 maythus serve as a connection for these ends, thereby avoiding multipleconnection points such as welds on the expanded diameter portion 102.Hence, a flat expanded diameter portion 102 may be provided, thatincreases the compactness of the device 100. Thereby no parts of thedevice 100 extend beyond the expanded diameter portion. By having suchcompact device 100, it may be easily positioned and manipulated at thetarget site. This is in contrast to cases having protruding parts atboth the distal and proximal ends, which could not attain the samedegree of compactness of the device. Further, due to the connectionmember 113 on the proximal end 106, the device 100 may be deliveredthrough the vena cava with improved safety to the patient. Delivery tothe high pressure arterial side of the vascular system is avoided, whichprovides for less complications and a medical procedure which is simplerto perform.

Similarly to the distal region 105 of the device 100 the proximal region106 may have a proximal rim 114 and a proximal surface 115. A distal end117 of the connection member 113 may have a second offset 116 inrelation to the proximal rim 114.

The proximal surface 115 may be confined to a region of the braiding 101between the connecting member 113 and the proximal rim 114. The diameterof the proximal surface 115 may be substantially equal to the diameterof the proximal rim 114, i.e. substantially equal to the diameter (B) inFIG. 1. Hence, the surface of the braiding 101 inside the proximal ring114 is sunk into the tubular member 103. This may provide increasedflexibility of the connecting member 113 in relation to the tubularmember 103, and also the device 100 becomes more compact, as the entirelength of the connecting member 108 may be sunk into the tubular member103. Alternatively, in other embodiments, the connecting member 113 mayprotrude proximally of the tubular portion.

FIG. 2 shows a perspective view of a medical implantable occlusiondevice 200 according to an embodiment of the invention. The stem 108 ofthe device 200 has an offset 111 from the distal rim 107 into thetubular member 103, providing the advantages as described above. Aconnecting member 113 in the form of a spherical ball is provided at theproximal end for connecting to a mating socket.

FIG. 3 shows a side view of the device 200 in FIG. 1. The expandeddiameter portion 102 is disc-shaped and is substantially concentricallyaligned with the tubular member 103.

FIG. 4 and FIG. 5 illustrate a method 500 of manufacturing a medicalimplantable occlusion device 100, 200, of a braiding 101 of at least onethread. The method comprises forming 501 the braiding 101 in a firstheat setting step to a first shape 405 comprising a tubular member 103and an expanded diameter portion 102. A secondary tool 401 is attached504 to the braiding 101 having the first shape 405. The braiding 101 isin the following formed 506 in a second heat setting step to a secondshape 406 by the secondary tool 401, as shown in FIGS. 4b-c . Thebraiding 101 maintains partly the first shape 405.

The method 500 comprises further welding 503 a bundle of threads of thebraiding 101 at a proximal end 106 of the tubular member 103 afterforming the first shape 405. Alternatively, the welding may be performedafter any manufacturing step. The method 500 comprises annealing 502,509, the braiding 101 in the heat setting steps after forming each ofthe first and second shapes 405, 406, respectively. By annealing thebraiding 101 the desired shapes 405, 406, can be maintained.

When forming the second shape 406 the method 500 comprises moving 507the secondary tool 401 into the braiding 101 to produce at least onerecess 402 into the tubular member 103. In FIG. 4b the secondary tool401 is partly moved towards tubular member 103, and in FIG. 4c thesecondary tool 401 is sunk into the tubular member 103 creating a recess402. Similarly, a secondary tool may be sunk into the proximal regionsuch that the connecting member 113 is sunk into the tubular body 103.

In forming the second shape 406 the method 500 comprises attaching 505the secondary tool around the stem 108 of the braiding 101. The stem 108is between and connects the tubular member 103 and the expanded diameterportion 102. When moving 508 the secondary tool 401 into the tubularmember the stem 108 is partly sunk into the tubular member 103 asillustrated in FIG. 4c . The braiding 101 in the second shape 406 withthe stem 108 recessed into the tubular member 103 may then be annealedand the secondary tool 401 may be removed. The second shape 406 may thencorrespond to the unloaded relaxed state of the braiding 101 of thedevice 100, 200. In other embodiments the secondary tool 401 may beattached to the braiding 101 at any location between the proximal region106 and the opposite end point of the device 100, 200, such as theexpanded diameter portion 102, for forming the device 100, 200, into asecond shape 406 that may be integral with the first shape 405, e.g. thefirst and second shapes 405, 406 may define the outside and insidecontours of the device 100,200, respectively.

The secondary tool may comprise at least two connectable portions 403,404 for attachment around the stem 108 of the braiding 108.

FIG. 6 illustrates a medical method 600 of occluding a shunt in a bodylumen, comprising providing 601 a device 100, 200, inserting 602 thedevice 100, 200 in a collapsed state into the shunt, expanding 603 andreleasing the device 100, 200, in the shunt, thus anchoring 604 thedevice 100, 200, in the shunt for occluding the latter by the device100, 200.

The device is that of the first aspect of the invention. Particularlyadvantageous anchoring and occlusion may be achieved while maintainingthe aforementioned flexibility of the device. The shunt is for instancea Patent Ductus Arteriosus (PDA), Arterial Venous Fistula (AVF),Arterial Venous Malformation (AVM), or a Para-Valvular Leak (PVL).

The present invention has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the invention. Thedifferent features and steps of the invention may be combined in othercombinations than those described. The scope of the invention is onlylimited by the appended patent claims.

More generally, those skilled in the art will readily appreciate thatall parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the teachings of thepresent invention is/are used.

The invention claimed is:
 1. A medical implantable occlusion devicecomprising a braiding of at least one thread, said braiding having anunloaded relaxed state and a stretched state and comprising, in saidunloaded relaxed state, an expanded diameter portion, a tubular memberextending along a longitudinal axis, said tubular member having a distalregion towards said expanded diameter portion and an opposite proximalregion, wherein a distal end of said distal region forms a distal rim ata distal end of the tubular member and a proximal end of said proximalregion forms a proximal rim at a proximal end of the tubular member, andwherein said tubular member tapers continuously inwardly from saidproximal rim to said distal rim and towards said longitudinal axis, and,a stem having a first end directly connected to said expanded diameterportion and a second end directly connected to said distal region,wherein said stem in said relaxed state is partly sunk into said tubularmember beneath said distal rim whereby said second end of said stem isdisplaced from said distal rim by a first offset along said longitudinalaxis, wherein said proximal region comprises a connecting member for adelivery device, wherein ends of said at least one thread are fixed tosaid connecting member, and wherein said expanded diameter portioncomprises returning loops of said at least one thread whereby oppositeends of said at least one thread forming said expanded diameter portionare fixed to said connecting member being the connection point for saidopposite ends.
 2. Occlusion device according to claim 1, wherein thedistance between said distal rim and said expanded diameter portion issubstantially smaller than the length of said stem.
 3. Occlusion deviceaccording to claim 1, wherein said stem is pivotable with respect tosaid tubular member around said second end of said stem.
 4. Occlusiondevice according to claim 1, wherein said stem is concentric withrespect to said tubular member.
 5. Occlusion device according to claim1, wherein said second end of said stem is connected to a distal surfaceof said distal region, wherein said distal surface is sunk into saidtubular member beneath said distal rim.
 6. Occlusion device according toclaim 5, wherein said distal surface is confined to a region of saidbraiding between said stem and said distal rim and having a diametersubstantially equal to the diameter of said distal rim.
 7. Occlusiondevice according to claim 1, wherein said tubular member is taperedtowards said expanded diameter portion.
 8. Occlusion device according toclaim 1, wherein said tubular member and said expanded diameter portionare elastically stretchable relative each other along said longitudinalaxis such that a first offset there between is variable in said relaxedstate, such that said device is self-contracting.
 9. Occlusion deviceaccording to claim 1, wherein said expanded diameter portion is a discshaped portion, and wherein the diameter of said expanded diameterportion is larger than a largest diameter of said tubular member. 10.Occlusion device according to claim 1, wherein the diameter of said stemis substantially smaller than a diameter of said tubular member. 11.Occlusion device according to claim 1, wherein said distal rim islocated in a plane substantially orthogonal to said longitudinal axis.12. Occlusion device according to claim 1, wherein a distal end of saidconnecting member is offset towards said expanded diameter portionrelative said proximal rim.
 13. Occlusion device according to claim 1,comprising a proximal surface between said proximal rim and saidconnecting member, wherein said proximal surface is sunk into saidtubular member.
 14. Occlusion device according to claim 1, wherein saidconnecting member is at least partly spherical.
 15. A medicalimplantable occlusion device comprising a braiding of at least onethread, said braiding having an unloaded relaxed state and a stretchedstate and comprising an expanded diameter portion, a tubular memberextending along a longitudinal axis, said tubular member having a distalregion towards said expanded diameter portion and an opposite proximalregion, wherein said distal region comprises a distal rim opposing saidexpanded diameter portion, wherein said proximal region comprises aproximal rim at a proximal end of the proximal region, and wherein saidtubular member tapers continuously inwardly from said proximal rim tosaid distal rim and towards said longitudinal axis, and a stem having afirst end connected to said expanded diameter portion and a second endconnected to said distal region, wherein said stem in said relaxed stateis partly offset towards said proximal region relative said distal rimand along said longitudinal axis, wherein said proximal region comprisesa connecting member for a delivery device, wherein opposite ends of saidat least one thread are attached to said connecting member. 16.Occlusion device according to claim 15, wherein said distal rim islocated in a plane substantially orthogonal to said longitudinal axis.17. Occlusion device according to claim 15, wherein a distal end of saidconnecting member is offset towards said expanded diameter portionrelative said proximal rim.
 18. Occlusion device according to claim 17,comprising a proximal surface between said proximal rim and saidconnecting member, wherein said proximal surface is sunk into saidtubular member.
 19. Occlusion device according to claim 18, wherein saidconnecting member is at least partly spherical.